Kornimate/medical-research-clean huggingface dataset:
phase ii clinical trial of uncaria tomentosa (cat´s claw) in patients with advanced solid tumors

Conditions: Solid Tumors

Summary: cat's claw (uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. patients and methods: this prospective phase ii study will assess the effects of a 100-mg dose of a dry extract of u. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. in addition, several biochemical and inflammatory parameters will be analyzed.


Eligibility criteria:
inclusion criteria: * individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy * individuals 18 years of age and older * creatinine levels up to twice the upper limit of normal (uln) * alanine (alt) and aspartate (asp) transaminase levels up to twice the uln and direct bilirubin (db) levels up to 1.5 times the uln * in cases with pre-existing liver disease, the alt, asp and db levels could be up to 2.5 times the uln exclusion criteria: * pregnant and breastfeeding women * individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy * severe kidney or liver failure * known hypersensitiveness to the components of the medication used * past history of emotional disorders that could interfere with the data collection.

Keywords: cat´s claw uncaria tomentosa quality of life no further therapeutic options
optimal intubating technique using videolaryngoscopy in patients with semi-rigid neck collar

Conditions: Cervical Spine Surgery; Intubation;Difficult

Summary: in the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.

for patients who need to limit the movement of the cervical spine, the tracheal intubation becomes difficult because the head must be positioned in the neutral position. most of all, with a semi-rigid neck collar that maintains the neutral position of the head and neck, movement is limited and the mouth is not well-opened make the environment of tracheal intubation worse, which result in hypoxia or throat complications related to general anesthesia. fortunately, it is possible that the development of video laryngoscope assists tracheal intubation easier for patients who have the limited movement of the cervical spine. however, the preferred intubation style and instrument selection for each operator are varied; the established method is required. in the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.

Eligibility criteria:
inclusion criteria: - adult patients (over 19 years of age) with asa class i-iii undergoing cervical spine surgery at our institution in the department of spine neurosurgery exclusion criteria: * when rapid sequence induction is required * when awake intubation is required * if a subject is on the medication for asthma * if as subject cannot read or understand the consent form of study
rheology of the pulmonary mucus

Conditions: Bronchial Mucus in COPD and Cystic Fibrosis

Summary: patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study. * a rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples. * another part will be done on frozen bronchial mucus samples


Eligibility criteria:
inclusion criteria: * male or female over 18 years of age. * patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment (mucus from respiratory physiotherapy sessions for patients with cystic fibrosis or copd, bronchial aspirations from the bronchial fibroscopy programme). exclusion criteria: * patient being opposed to the use of his mucus samples and data for this research. * patient protected by law (guardianship or curatorship), subject deprived of liberty
study of the clinical and biological efficacity of naaxia sine® in vernal keratoconjunctivitis

Conditions: Keratoconjunctivitis, Vernal

Summary: to assess the clinical and biological efficacity of preservative free naaga eyes drops in vernal keratoconjunctivitis

the objective of this pilot study is to evaluate the clinical and biological efficacy of preservative free naaga eyedrops in vkc -by in particular the levels of ecp and mpo in tears- comparatively to the activity of levocabastine eyedrops.

Eligibility criteria:
inclusion criteria: * patients with vernal keratoconjunctivitis, * mild or moderate : clinical score \>3 and \<= 14, calculated from 4 major symptoms (itching, tearing, photophobia, foreign body sensation) and 6 major clinical signs (conjunctival erythema, conjunctival chemosis, discharge, papillae, limbal infiltrates and corneal epithelial disease) * age \>= 4 years old exclusion criteria: * no occurrence of ocular trauma or infection (within the 3 months preceding the study), * no ocular medical treatment (topical or not) within the 5 days preceding the study, * no ocular laser (within the 3 previous months), * no ocular surgery (within the previous year), * patient who signs the informed consent form (or his/her parents or legal guardian in the case of underage patient).
aspirin and/or folic acid in preventing recurrent colorectal polyps

Conditions: Colorectal Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. the use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously. purpose: randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.

objectives: * determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are randomized to 1 of 4 treatment arms. * arm i: patients receive oral aspirin and oral folic acid daily. * arm ii: patients receive oral aspirin and oral placebo daily. * arm iii: patients receive oral placebo and oral folic acid daily. * arm iv: patients receive 2 oral placebos daily. in all arms, treatment continues for 3 years in the absence of unacceptable toxicity. after completion of the 3-year intervention, all patients undergo a surveillance colonoscopy. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 1,300 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed colorectal adenoma removed within the past 6 months * greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal * or * any size with a history of prior colorectal adenoma removal(s) * removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery * removal must be considered complete with follow-up to be done within 6 months * no prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy) patient characteristics: age: * 75 and under performance status: * not specified life expectancy: * not specified hematopoietic: * no active bleeding disorders hepatic: * not specified renal: * not specified cardiovascular: * no unstable heart conditions pulmonary: * no unstable asthma other: * not pregnant and no potential to become pregnant within the next 3 years * no unstable diabetes * no active upper gastrointestinal ulceration * no known aspirin intolerance or sensitivity * no other serious medical conditions that would preclude study participation prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * see disease characteristics other: * no other concurrent folic acid * no concurrent anticoagulants * no other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)

Keywords: colon cancer rectal cancer
effect of superficial cervical plexus block on the postoperative quality of recovery

Conditions: Cervical Disc Prolapse

Summary: pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted as moderate in severity, often needing oral opioid analgesics. in addition, these patients are more prone for postoperative respiratory complication due to airway edema secondary to surgical retraction or wound hematoma. opioid analgesics provide good pain control but postoperative nausea and vomiting and respiratory depression are undesirable in these patients who are at risk for postoperative wound hematoma and airway edema the use of multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after ambulatory procedures at most surgery centers throughout the world . the purpose of this study is to determine whether superficial cervical plexus block will improve the postoperative quality of recovery as measured by quality of recovery 40 questionnaire (qor-40) in patients undergoing elective anterior cervical discectomy and fusion.

anterior cervical discectomy and fusion is increasingly being done as a day surgery or short stay surgery. postoperative pain is the leading cause of unplanned hospital admissions following day surgery, a major source of dissatisfaction and often impairs the quality of recovery. opioid analgesics alone are not always effective and may also worsen the postoperative nausea and vomiting and in turn the postoperative recovery. this study is designed to find out if an injection of freezing on the side of neck around the nerves (superficial cervical plexus block) improves the quality of recovery from anesthesia and surgery by reducing the pain, analgesic consumption after anterior cervical spine surgery. primary outcome measure the primary outcome measure is the global qor-40 aggregate score at 24 hours after surgery. secondary outcome measures * postoperative pain scores (first 24 hours) * total analgesic consumption (first 24 hours) * time for first opioid administration * postop nausea and vomiting (first 24 hours) * post operative sedation (first 24 hours)

Eligibility criteria:
inclusion criteria: * all adult patients * aged 18-80 years * with asa class i - iii * undergoing anterior cervical disc surgery in supine position exclusion criteria: 1. in patients who are allergic to local anesthetics 2. asa- iv patients 3. lack of informed consent 4. pregnant patient

Keywords: superficial cervical plexus block quality of recovery
a phase 1/2 trial of donor regulatory t-cells for steroid-refractory chronic graft-versus-host-disease

Conditions: Graft vs Host Disease

Summary: phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor clinimacs-selected regulatory t cells

phase 1/2 clinical study evaluating safety (phase 1) and preliminary efficacy (phase 2) of donor regulatory t cells for patients with steroid-refractory chronic graft versus host disease (gvhd) after allogeneic hematopoietic stem cell transplantation (hsct). patients must have persistent signs and symptoms despite the use of prednisone or equivalent at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete resolution of signs and symptoms. occasional patients requiring lower doses of prednisone will be eligible if associated with other immunosuppressive drugs. phase 1 clinical trial will include groups of 5 patients sequentially treated with: 0.5 x 10ˆ6, 1.0 x 10ˆ6, 2-3 x 10ˆ6 donor treg/kg. phase 2 clinical trial will include another 5 to 10 patients treated with mtd. donor treg will be selected by the following sequential steps: 1. - negative depletion of cd8 and cd19 cells 2. - positive selection of cd25 cells

Eligibility criteria:
inclusion criteria: 1. patients must have persistent signs and symptoms despite the use of prednisone or equivalent at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete resolution of signs and symptoms. occasional patients requiring lower doses of prednisone will be eligible if associated with other immunosuppressive drugs. 2. stable immunosuppressive medication in the 4 weeks prior to initiation of treatment 3. ps 0-2 ecog 4. adequate liver, kidney, lung and hematopoietic system functions exclusion criteria: 1. pediatric patients 2. pregnant women 3. ongoing prednisone requirement \>1 mg/kg/day (or equivalent) 4. concurrent use of calcineurin-inhibitor plus sirolimus (either agent alone is acceptable) 5. new immunosuppressive medication in the 4 weeks prior 6. extra-corporeal photopheresis or rituximab therapy in the 4 weeks prior 7. exposure to t-cell or il-2 targeted medication (e.g. atg, alemtuzumab, basiliximab, denileukin diftitox) within 100 days prior 8. donor lymphocyte infusion within 100 days prior 9. active malignant relapse 10. active uncontrolled infection 11. hiv-infected patients

Keywords: allogeneic hematopoietic stem cell transplantation graft vs host disease regulatory t cells
phase 2 study of khk4577

Conditions: Atopic Dermatitis

Summary: this study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral khk4577 for 6 weeks in patients with atopic dermatitis. pharmacokinetics of khk4577 will also be assessed.


Eligibility criteria:
inclusion criteria: * subject has signed voluntarily the written informed consent form to participate in this study. * subject has been diagnosed as atopic dermatitis according to guidelines for management of atopic dermatitis (2009). * rajka \& langeland criteria of \>/= 4.5 at screening visit * investigator's global assessment (iga) score of \>/= 3 at screening visit exclusion criteria: * evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug. * subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent. * subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent. * subject has complications / history of drug abuse or alcoholism. * subject has drug allergy or history of allergic reaction to a drug medicine. * subject has a significant concurrent medical conditions as defined in the study protocol. * subject is breast-feeding, pregnant or planning to become pregnant in this study period.
magnetic resonance imaging in patients with trigeminal neuralgia

Conditions: Trigeminal Neuralgia (TN)

Summary: this study intends to use mri technology to analyze the dynamic changes and microstructure changes of the brain network in patients with trigeminal neuralgia, evaluate the blood-brain barrier and water exchange rate, and further analyze their correlation with clinical indicators, so as to explore the changes in brain structural plasticity and potential neural mechanisms


Eligibility criteria:
inclusion criteria: * the diagnosis was tn according to the ichd. * patients requiring surgical treatment due to ineffective or intolerant treatment with carbamazepine or oxasepine before operation; * first surgical treatment; * right-handed dominant; * there was no significant loss of sensation exclusion criteria: * secondary tn; * associated with other types of chronic pain or neuropsychiatric disorders; * history of head trauma or stroke or cerebrovascular ischemia; * history of microvascular decompression or other treatments (gamma knife radiosurgery, etc.); * unable to cooperate independently; * contraindications, such as uncontrolled infection, coagulopathy, etc.; * mricontraindications (e.g., pacemaker, claustrophobia, etc.)
a study of dox-sl in the treatment of aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to evaluate the safety and effectiveness of stealth liposomal doxorubicin hydrochloride (dox-sl) in the long-term treatment of aids-related kaposi's sarcoma (ks) in patients who previously had good responses to dox-sl in controlled studies of limited duration, or those with ks who discontinued treatment with another kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. to provide a defined protocol for kaposi's sarcoma patients for whom dox-sl therapy is indicated.

patients receive dox-sl every 3 weeks for a maximum of 20 cycles (including any cycles from a previous dox-sl study). ks lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. patients who respond will be followed every 2 months for up to 1 year. study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * prophylaxis for pcp, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month. * maintenance therapy for tuberculosis, fungal, and herpes infections. * therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. * foscarnet or ganciclovir for cmv infection. * colony stimulating factors and erythropoietin. patients must have: * moderate to severe aids-related kaposi's sarcoma. * documented anti-hiv antibody. * no active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). note: * eligible ks patients include those who have discontinued therapy in the control arm of a dox-sl ks study because of side effects or inadequate efficacy or other ks patients for whom dox-sl is believed to be indicated. patients must not be eligible for other liposome technology protocols comparing dox-sl with established therapies. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant cardiac disease. * confusion or disorientation. concurrent medication: excluded: * other cytotoxic cancer chemotherapy. patients with the following prior conditions are excluded: * prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function. * history of idiosyncratic or allergic reaction to anthracyclines. * history of major psychiatric illness. prior medication: excluded within the past 4 weeks: * cytotoxic chemotherapy (other than in a qualifying liposome technology protocol). * interferon treatment. prior treatment: excluded within the past 3 weeks: * radiation or electron beam therapy.

Keywords: sarcoma, kaposi liposomes doxorubicin acquired immunodeficiency syndrome drug carriers
clinical performance of a silicone hydrogel contact lens following one night of extended wear

Conditions: Refractive Errors

Summary: the purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 night of extended wear.

subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. subjects will be expected to attend 4 scheduled study visits. the lenses will be worn continuously from the time of dispense on day 1 until lens collection at the day 2 follow-up/exit visit.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an approved informed consent form. * successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week in either a daily wear or extended wear modality. * best corrected visual acuity (bcva) of 20/25 or better in each eye. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the investigator. * current biofinity® lens wearer. * pregnant or breast-feeding. * other protocol-specified exclusion criteria may apply.

Keywords: contact lens extended wear contralateral wear vision correction